Transduction for AAV with Sean Hart

Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.

Bill Williams, AAPS, compares KinetiSol and spray drying for amorphous solid dispersions, covering 75% drug loading, pill burden, weakly basic drug release, and process limits.

Pauric Bannigan, Intrepid Labs, explains how physics-informed machine learning aids formulation and why regulators still want experimental data.

Pauric Bannigan, Intrepid Labs, explains where AI speeds formulation decisions, why data is the bottleneck, and how active learning trains models with far less data.

Stephanie Johnson, Pfizer, explains how off-platform triggers, single-owner risk registers, and traceable prior knowledge keep protein formulation programs on track.

Stephanie Johnson, Pfizer, discusses how platform formulations moved 2 Pfizer protein programs to IND in 8 months by redistributing, not removing risk.

Univar Solutions scientists developed a lidocaine cream built on starch, sorbitol, coconut oil, and beeswax that matched a commercial benchmark on viscosity, assay, and hydration.

FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.